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ABX203 (HeberNasvac) Granted Cuban Marketing Authorization

"ABIVAX (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), an emerging leader in developing and commercializing anti-viral and vaccine therapies for diseases like HIV/AIDS and chronic Hepatitis B (CHB) and the Center for genetic Engineering and Biotechnology (CIGB), a global leader in biotechnology, today announced that CECMED, the Cuban regulatory authorities, granted the CIGB their first marketing authorization application for ABX203, a first-in-class therapeutic vaccine for treatment of CHB, under the trade name HeberNasvac."

http://www.businesswire.com/news/home/20151208006286/en/ABIVAX-ABX203-HeberNasvac-Granted-Cuban-Marketing-Authorization

35 Responses
Avatar universal
Can someone explain more what this authorization means in practice ? That im may be used by medicans not only in clinical trials ?
What can we expect from that vaccacine ? Only keeping hbv dna and ALT low or also HBsAg kicked down ?
Avatar universal
It means that it can be prescribed and obtained in Cuba. It's effectiveness as mono therapy is similar to a course of interferon, but one cannot  expect hbsag seroconversion from it. What we know at this time point all derives from a small trial in Bangladesh,  that was presented at a previous aasld and discussed here several times.
Avatar universal
let's look for cheap flights europe/cuba for this 2016 an interesting add on for sure
Avatar universal
Ok, final effect is similar to inteferon but do you think combo ABX with interferon would make sense or it rather works similar way so it's just doubling ?
Avatar universal
Just wondering, is there any difference between ABX203 and interferon in terms of side effects, costs, or uses?

Thank you.
Avatar universal
I would expect ifn and hebernasvac to work mildly synergistic. I still don't think that this combo would get more than a few percentage points improvement in hbsag loss.

The side effects of the vaccine should be much milder than ifn, that was also reported in that trial. Cost will be an interesting question, should be affordable if produced in Cuba.
Avatar universal
What was the data saying in their phase 3 trials in terms of the number of people getting SVR?

If its approved for use in cuba does it  it will granted approval in Europe?
Avatar universal
As far as their HQ in France they will definitely approve at least in France then over all Europe. Imo
Avatar universal
Abivax is currently running the phase III trial in Asia. There are no data yet.
Cuba approved it apparently since it is their invention, based on the first smaller trial.
Europe  will not approve it before the big trial is all finished.
Avatar universal
It seems that they actually only granted the application for the marketing, not the marketing yet. Thus it might take a while, like a year, for the actual marketing approval. I was to optimistic in my wording above.
Avatar universal
You mean one year for Europe ?
Avatar universal
Sorte according to his comment another one year till the market in Cuba.
Avatar universal
But its surely a signal of intent from all involved in cuba no? Also that getting this on the market long prior to any competitors will give them the opportunity to jack up the price maybe?
Avatar universal
It is a very positive signal from the cuban authorities. It is unclear however if this would speed up approval in the EU, certainly not before the phase III trial is completed inclusive the follow up.
Avatar universal
Its kinda of funny that cuba has never really stood out as somewhere with high hep b prevelance.

I know they do as a nation have a good reputation for medical facilities though
Avatar universal
has anyone knowledge about the way cuba put drugs on the market?

where shall we look/ask for this new vaccine, hospitals, government agencies, normal pharmacy or directly the vaccine producer in cuba?
Avatar universal
The Cuban center  that developed the vaccine has a website , with news.
http://www.cigb.edu.cu/index.php/en/

Interestingly, the approval of the start of the marketing application is not yet part of the news there.
Avatar universal
i dont know why the main target of drug Makers is to control disease not fully cure it! they don't even care to talk about HbsAg Quantitative Before and After?
Avatar universal
or why not they report if there is any hbsag loss associated with ABX203 use
Avatar universal
Frredands u r in here too...lol
Avatar universal
Steff, article says that will be granted soon in late 2016 for Europe. So, we are close to defeat it
Avatar universal
It might say that but its such a highly regulated process with many pit falls.

Lets hope they are correct
Avatar universal
Cheers to Cuba,
Important that finally, after nucs another hope is coming out soon.
Tickets for Cuba
Avatar universal
http://www.cigb.edu.cu/index.php/en/

no answer from these guys, maybe international contracts problems or maybe they dont look at emails
1 Comments
They never reply. Maybe if you write in Spanish?
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